Subject: Brukinsa 3411-A SGM P2023b
Policy:
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
A. FDA-Approved Indications
Brukinsa is a kinase inhibitor indicated for the treatment of
adult patients with:
1. Mantle cell lymphoma (MCL) who have received at least
one prior therapy.
2. Waldenstrom’s macroglobulinemia (WM).
3. Relapsed or refractory marginal zone lymphoma (MZL)
who have received at least one anti-CD20-based regimen.
4. Chronic lymphocytic leukemia (CLL) or small lymphocytic
lymphoma (SLL)
B. Compendial Uses
1. Mantle Cell Lymphoma
2. Chronic Lymphocytic Leukemia/Small Lymphocytic
Lymphoma
3. Gastric MALT Lymphoma (Extranodal Marginal Zone
Lymphoma of the Stomach)/Non-gastric MALT Lymphoma
(Extranodal Marginal Zone Lymphoma of Nongastric
Sites)
4. Nodal Marginal Zone Lymphoma
5. Splenic Marginal Zone Lymphoma
6. Waldenstrom Macroglobulinemia/Lymphoplasmacytic
lymphoma/Bing-Neel Syndrome
7. Hairy Cell Leukemia
8. Follicular Lymphoma
All other indications are considered experimental/investigational
and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate
the prior authorization review:
Test results confirming TP53 mutation, where applicable
III. CRITERIA FOR INITIAL APPROVAL
A. Mantle Cell Lymphoma
Authorization of 12 months may be granted for treatment of
mantle cell lymphoma when any of the following criteria are
met:
1. The requested medication will be used as a single agent
when the member has received at least one prior therapy.
2. The requested medication will be used as a component of
TRIANGLE regimen for members with TP53 mutations for
induction therapy.
TRIANGLE regimen = alternating RCHOP (rituximab,
cyclophosphamide, doxorubicin, vincristine, and
prednisone) + Brukinsa/RDHAP (rituximab,
dexamethasone, and cytarabine) + platinum (carboplatin,
cisplatin, or oxaliplatin) regimen
3. The requested medication will be used in combination
with rituximab for maintenance therapy.
B. Chronic Lymphocytic Leukemia (CLL)/Small
Lymphocytic Lymphoma (SLL)
Authorization of 12 months may be granted for treatment of
CLL/SLL when used as a single agent.
C. Marginal Zone Lymphoma
Authorization of 12 months may be granted for treatment of
marginal zone lymphoma, including gastric MALT lymphoma
(extranodal marginal zone lymphoma of the stomach), non-
gastric MALT lymphoma (extranodal marginal zone
lymphoma of nongastric sites), nodal marginal zone
lymphoma and splenic marginal zone lymphoma, when used
as subsequent therapy for members who have received an
anti-CD20 based-regimen (e.g., rituximab or obinutuzumab).
D. Waldenstrom Macroglobulinemia/Lymphoplasmacytic
Lymphoma/Bing-Neel Syndrome
Authorization of 12 months may be granted for treatment of
Waldenstrom macroglobulinemia/Lymphoplasmacytic
lymphoma when used as a single agent or for the treatment
of Bing-Neel syndrome when used as a single agent or in
combination with rituximab.
E. Hairy Cell Leukemia
Authorization of 12 months may be granted for treatment of
hairy cell leukemia when both of the following criteria are
met:
1. The member had disease progression after receiving
therapy for relapsed or refractory disease
2. The requested medication will be used as a single agent.
F. Follicular Lymphoma
Authorization of 12 months may be granted as third line and
subsequent therapy in combination with obinutuzumab
(Gazyva) for treatment of follicular lymphoma.
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization for an
indication listed in Section III when there is no evidence of
unacceptable toxicity or disease progression while on the current
regimen.
Place of Service:
Outpatient
The above policy is based on the following references:
- Brukinsa [package insert]. San Mateo, CA: BeiGene USA, Inc.; December 2023.
- The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed January 26, 2024.
- Eskelund CW, Dahl C, Hansen JW, et al. TP53 mutations identify younger mantle cell lymphoma patients who do not benefit from intensive chemoimmunotherapy. 2017;130(17):1903-1910.
- Clinical Consult: CVS Caremark Clinical Programs Review. Focus on Hematology-Oncology-Lymphoma. August 2023.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
February 23, 2024
